Ensuring the Safety of Marketed Medical Devices

Index of Slides

1. Ensuring the Safety of Marketed Medical Devices
2. Outline
3. CDRH’s mission is:
4. CDRH also is responsible for:
5. CDRH Postmarket Program: Challenges and Opportunities
6. Medical Devices
7. Profile of the Domestic Medical Device Industry
8. Challenges to Assuring Postmarket Device Safety
9. Adverse Event Reporting Challenges
10. What we are doing today
11. We have established clear goals
12. We have aligned our FY 06 Priorities with those goals
13. We are strengthening Condition of Approval studies
14. We are improving medical device reporting
15. We are improving targeted surveillance systems: MedSun
16. We are focusing on Risk-Based Inspections
17. We are implementing Third-Party Inspections
18. We are communicating risk/benefit information
19. We are refining our communication strategy
20. What we will be doing tomorrow
21. Postmarket Safety Inventory
22. Action Steps
23. 1. Develop a Culture of Collaboration
24. 2. Develop World Class Data Sources and Systems
25. 3. Enhance Risk/Benefit Communication
26. 4. Improve Enforcement Strategies for Postmarket Issues
27. Components of CDRH’s Postmarket Program
28. No Title

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